Modular implant delivery and positioning system

ABSTRACT

This document discusses, among other things, systems and methods for robotically assisted implantation of an implant in a patient. A system includes an external positioning unit configured to engage an elongate member of the implant, and a control console communicatively coupled to the external positioning unit. The control console may have a user interface that enables a user to input motion control instructions. The control console may generate a motion control signal, according to a specific motion control instruction, to control the external positioning unit to propel the implant into a target implant site. The system may be used to robotically control the delivery and positioning of a cochlear implant during a hearing-preservation cochlear implant surgery.

CLAIM OF PRIORITY

This patent application is a continuation of U.S. patent applicationSer. No. 16/486,030, filed Aug. 14, 2019, which application is a U.S.National Stage Filing under 35 U.S.C. 371 from International ApplicationNo. PCT/US2018/018182, filed Feb. 14, 2018, and published as WO2018/152203 on Aug. 23, 2018, which application claims the benefit ofpriority to U.S. Provisional Patent Application No. 62/458,846, filedFeb. 14, 2017, and U.S. Provisional Patent Application No. 62/573,487,filed Oct. 17, 2017 which are incorporated by reference herein in theirentirety. This patent application also is a continuation of U.S. patentapplication Ser. No. 15/759,643, filed Mar. 13, 2018, which applicationis a U.S. National Stage Filing under 35 U.S.C. 371 from InternationalApplication No. PCT/US2016/039342, filed Jun. 24, 2016, and published asWO 2017/048342 on Mar. 23, 2017, which application claims the benefit ofpriority to U.S. Provisional Patent Application No. 62/218,359, filedSep. 14, 2015 which are incorporated by reference herein in theirentirety.

TECHNICAL FIELD

This document relates generally to medical systems and more particularlyto systems, devices, and methods for robotic control of delivery andpositioning of an implant.

BACKGROUND

The cochlea is the auditory portion of the inner ear. It comprises aspiraled, hollow, conical chamber of bone in which sound waves propagatefrom the base to the apex of the cochlea. The sound waves vibrate theperilymph that moves hair cells in the organ of Corti, converting thevibrations to electrical signals that are sent to the cochlear nerve.The hair cells and nerves in the basal or outer region of the spiraledcochlea are more sensitive to higher frequencies of sound, and arefrequently the first part of the cochlea to lose sensitivity. The apicalor inner region of the spiraled cochlea is more sensitive to lowerfrequencies.

Moderate to profound hearing loss affects a large amount of peopleworldwide, and may have a significant impact on a patient physical andmental health, education, employment, and overall quality of life.Hearing loss may be caused by partial damage to the cochlea. Manypatients with various degrees of hearing loss have partial damage to thecochlea in the high-frequency regions (basal cochlea) from common causessuch as noise exposure, drugs, genetic mutations or aging, but mayretain adequate low-frequency hearing.

Cochlear implants have been used to treat patients with hearing loss. Acochlear implant is a medical device that comprises an external soundprocessor, a subcutaneously implantable stimulator, and an electrodeassembly sized and shaped for cochlear insertion. The sound processorcan convert sound signals into electrical signals, and transmit theelectrical signals to the implantable stimulator. Based on the physicalproperties (e.g., frequencies) of the received electrical signals, thestimulator can generate electrical impulses to stimulate specificregions in the cochlea via an array of electrodes on the electrodeassembly surgically inserted into the cochlea. The region forstimulation may be determined based on the frequencies of the receivedelectrical signals. For example, higher frequencies may result instimulation at the outer or basal cochlear region, and lower frequenciesmay result in stimulation at the inner or apical cochlear region.

For patients who have lost high-frequency hearing and consequently havesignificant difficulty with word understanding but who have substantialresidual, low-frequency hearing function in apical cochlea, a shortelectrode assembly may be indicated to electrically stimulate the basalor outer cochlea to restore high-frequency hearing. A cochlear implantsurgery may be performed by a surgeon to manually insert the electrodeassembly into the damaged portion of a patient cochlea (e.g., basalcochlea), while avoiding or minimizing any trauma to the undamagedcochlear regions to preserve the low-frequency hearing function. Thecochlear implant may be used together with a hearing aid thatacoustically stimulates the undamaged low-frequency sensitive apicalcochlea.

Intracochlear trauma can occur from large pressure spikes generatedduring the insertion of cochlear implant electrodes. Cochlear implantsurgery can also involve insertion of a guide sheath or tube near orpartially into the cochlea. Insertion of any solid or flexible bodies,tubes, or sheaths into the cochlea could elicit similar fluid and forcespikes. These pressures spikes may be of sufficient intensity to causetrauma similar to that of an acoustic blast injury and are one likelysource for postoperative loss of residual hearing. Similar to theinsertion trauma cause by electrode insertion, the manual insertion of asheath or other solid body/tube manually into the cochlea may causeintracochlear fluid pressure spikes and result in intrachochlear damage.

SUMMARY

A hearing-preservation cochlear implant surgery involves implanting anelectrode assembly into the damaged cochlear region, while avoiding anytrauma to the undamaged cochlear region to preserve any normal residualhearing. In current cochlear implant surgery, a surgeon manually insertsan electrode assembly into patient cochlea. However, a complete manualmaneuvering of the electrode assembly may cause undesirable outcome insome patients. For example, manual insertion of electrode assembly maylack precision in implant position and motion control, such as thecontrol of insertion rate, distance, or forces applied to the implantfor advancing the electrode assembly to the target cochlear region. Thismay cause damage to fragile cochlear structures such as local trauma tocochlea wall and hair cells, and result in residual hearing loss.

Complete manual maneuvering of the electrode assembly may also besubject to high inter-operator variability among surgeons. Theinter-operator variability is demonstrated in dramatic differences inpatient outcomes between institutions and surgeons of differing skilllevels. Some patients undergoing hearing-preservation cochlear implantsurgery may experience additional hearing decline weeks to years aftersurgery. Such a continual decline in hearing function may be attributedto an inflammatory response to the trauma inflicted during an initialcochlear implant surgery. Some clinical studies show that techniquesaimed at reducing electrode-insertion forces during surgery haveimproved patient hearing preservation outcomes. For at least reasons,the present inventors have recognized that there remains a need toimprove patient outcome following a hearing-preservation cochlearimplant surgery, particularly systems, apparatus, and methods thatenhance surgical precision in implant delivery and positioning, andreduce the risk of perioperative trauma to undamaged cochlea region.

This document discusses, among other things, systems, devices, andmethods for robotically assisted implantation of an implant in apatient, such as for delivering and positioning a cochlear implant fortreating hearing loss in a hearing-preservation cochlear implantsurgery. The systems and devices discussed can also be adapted forrobotically controlling insertion of a guide sheath or tube that may beused in conjunction with electrode implantation. The modular systemdiscussed herein includes an external positioning unit reversiblyinterfacing with and securely engaging an implant such as a cochlearimplant having an elongate member, and a computerized control unit forrobotically controlling the external positioning unit to regulate themotion of the implant. The computerized control unit may have a userinterface that enables a user (e.g., a surgeon) to program variousmotion control parameters or to select an implantation protocol. Thesystem may include sensors providing feedback on the position or themotion of the implant, or the force or friction applied to the implantduring the implantation procedure. The computerized control unit mayregulate the motion of the implant based on user input and the sensorfeedback. The control systems may also interface with external systemsproviding electrophysiological measures to enable closed loop feedbackon electrode positioning in real-time during implantation.

Example 1 is a system for robotically assisted implantation of animplant in a patient. The system comprises an external positioning unitconfigured to engage the implant and robotically deliver and positionthe implant into a target implantation site, and a control consolecommunicatively coupled to the external positioning unit. The controlconsole may include a controller circuit configured to generate a motioncontrol signal, according to a specific motion control instruction, forcontrolling the external positioning unit to robotically deliver andposition the implant into the target implantation site.

In Example 2, the subject matter of Example 1 optionally includes theimplant that may include an elongate member. The external positioningunit may include a coupling unit configured to interface with theelongate member of the implant, and to frictionally move the elongatemember in response to the motion control signal.

In Example 3, the subject matter of Example 2 optionally includes theimplant that may include a cochlear implant having an electrode arraydisposed on the elongate member.

In Example 4, the subject matter of any one or more of Examples 2-3optionally includes the coupling unit that may include at least tworollers arranged and configured to: engage, through compression betweenrespective radial outer surfaces of the at least two rollers, at least aportion of the elongate member of the implant; and to rotate to propelthe implant via friction generated by the compression.

In Example 5, the subject matter of Example 4 optionally includes amotor coupled to at least one of the at least two rollers via a powertransmission unit to drive rotation of the at least two rollers.

In Example 6, the subject matter of Example 4 optionally includes the atleast two rollers where the radial outer surface of at least one of therollers is covered with frictious material.

In Example 7, the subject matter of any one or more of Examples 5-6optionally includes the at least two rollers where the radial outersurface of at least one of the rollers has a radially concave profile.

In Example 8, the subject matter of Example 5 optionally includes themotor that may be included in the external positioning unit, and theexternal positioning unit further includes a power source electricallycoupled to the motor.

In Example 9, the subject matter of Example 8 optionally includes thepower source that may include a rechargeable power source.

In Example 10, the subject matter of Example 5 optionally includes themotor that may be included in the control console. The motor may becoupled to the at least one of the at least two rollers via a shaftrunning between the control console and the external positioning unit.

In Example 11, the subject matter of any one or more of Examples 2-10optionally includes first and second motors. The external positioningunit may include first and second coupling units each interfacing with arespective portion of the elongate member of the implant. The firstmotor, via a first power transmission unit, may be coupled to the firstcoupling unit to actuate a translational motion of the elongate member.The second motor, via a second power transmission unit, may be coupledto the second coupling unit to actuate a rotational motion of theelongate member.

In Example 12, the subject matter of any one or more of Examples 5-11optionally includes a manual drive-wheel coupled to at least one of theat least two rollers. The manual drive-wheel is configured to enablemanual rotation of the at least one of the at least two rollers.

In Example 13, the subject matter of any one or more of Examples 2-12optionally includes a sheath extended from the external positioning unitto a surgical entrance of the target implantation site. The sheath maybe configured to at least partially enclose the elongate member toprovide resilient support to the electrode array during implantation.

In Example 14, the subject matter of any one or more of Examples 1-13optionally includes an indicator on the external positioning unit toalert a specific implant status.

In Example 15, the subject matter of any one or more of Examples 1-14optionally includes the external positioning unit that may include afixation member configured to detachably affix the external positioningunit to the patient.

In Example 16, the subject matter of Example 15 optionally includes thefixation member that may include one or more of a screw, a pin, a nail,a wire, a hook, a suture, or a magnet.

In Example 17, the subject matter of any one or more of Examples 1-16optionally includes the external positioning unit that may include anexterior patient-contact surface equipped with gripping elementsconfigured to frictionally affix the external positioning unit to thepatient.

In Example 18, the subject matter of any one or more of Examples 5-12optionally includes the controller circuit that may be configured togenerate the motion control signal to control the motor to regulate oneor more motion parameters of the elongate member/The motion parametersinclude one or more of: a movement rate; a movement direction ororientation; a movement distance; a position of a distal end of theelongate member; or an amount of force imposed on the elongate member.

In Example 19, the subject matter of Example 18 optionally includes thecontroller circuit communicatively coupled to the motor via a wiredconnection.

In Example 20, the subject matter of Example 18 optionally includes thecontroller circuit communicatively coupled to the motor via a wirelesscommunication link.

In Example 21, the subject matter of any one or more of Examples 1-20optionally includes the control console that may include a userinterface module configured to receive from a user one or more motionparameters. The motion parameters include one or more of: a targetmovement rate; a target movement direction or orientation; a targetmovement distance; a target position of a distal end of the elongatemember; or a target amount of force imposed on the elongate member.

In Example 22, the subject matter of Example 21 optionally includes theuser interface module that may be configured to receive informationabout patient tonotopic hearing loss pattern. The controller circuit maybe configured to control the external positioning unit to deliver andposition at least a portion of the elongate member of the implantfurther according to the received information about the patienttonotopic hearing loss pattern.

In Example 23, the subject matter of any one or more of Examples 5-12and 18-20 optionally includes the motion control instruction that mayinclude selectable enabling of a robotic mode for robotically assistedmotion control of the elongate member of the implant, or a manualoverride mode for manual motion control of the elongate member of theimplant.

In Example 24, the subject matter of any one or more of Examples 2-13,18-20 and 23 optionally includes one or more sensors configured to senseone or more motion parameters of the implant during implantation. Thecontrol console is configured to control the external positioning unitto propel the elongate member of the implant according to the sensed oneor more motion parameters.

In Example 25, the subject matter of Example 24 optionally includes theone or more sensors that may include a Hall-effect sensor configured tosense a position or a displacement of the elongate member of the implantinside the patient.

In Example 26, the subject matter of any one or more of Examples 24-25optionally includes a force sensor configured to sense an indication offorce or friction imposed on the elongate member of the implant duringimplantation.

In Example 27, the subject matter of any one or more of Examples 24-26optionally includes the one or more sensors that are included in theexternal positioning unit.

In Example 28, the subject matter of any one or more of Examples 21-22optionally includes the user interface module that may include an outputmodule configured to generate a human-perceptible presentation of one ormore motion parameters of the implant.

In Example 29, the subject matter of any one or more of Examples 1-28optionally includes a peripheral control unit communicatively coupled tothe external positioning unit or the control console. The peripheralcontrol unit may be configured to control the external positioning unitto propel the implant. The peripheral control unit including one or moreof a foot pedal or a handheld device.

Example 30 is a non-implantable apparatus for robotically assistedimplantation of a cochlear implant having an electrode array disposed onan elongate member. The apparatus comprises: an external positioningunit including at least two rollers arranged to compress at least aportion of the elongate member between portions of a radial outersurface of each roller of the at least two rollers to transmittranslational or rotational forces on the elongate member; wherein atleast one of the at least two rollers is coupled to, and driven by, arobotically controlled motor.

In Example 31, the subject matter of Example 30 optionally includes theexternal positioning unit that may include one or more of: the motor; apower transmission unit interacting with the motor and the at least oneof the at least two rollers; or a communicator circuit configured toreceive a motion control signal for controlling the motor.

In Example 32, the subject matter of any one or more of Examples 30-31optionally includes the external positioning unit that may include oneor more sensors configured to sense one or more motion parameters of thecochlear implant during implantation.

Example 33 is a method for delivering and positioning an electrode of acochlear implant on an elongate member into a target implantation siteof a patient via an external robotically assisted implantation system.The method comprises steps of: establishing a communication between anexternal positioning unit and a control console; engaging at least aportion of the elongate member of the cochlear implant to the externalpositioning unit; affixing the external positioning unit to the patientvia a fixation member of the external positioning unit; and roboticallycontrolling the external positioning unit, via the control console, todeliver and position the cochlear implant into the target implantationsite.

In Example 34, the subject matter of Example 33 optionally includes theengagement of the elongate member that may include engaging at least aportion of the elongate member of the cochlear implant throughcompression between respective radial outer surfaces of at least tworollers.

In Example 35, the subject matter of any one or more of Examples 33-34optionally includes the robotic control of the external positioning unitthat may include controlling a motor coupled to the external positioningunit, and regulating one or more motion parameters of the elongatemember. The motion parameters may include one or more of: a movementrate; a movement direction or orientation; a movement distance; aposition of a distal end of the elongate member; or an amount of forceimposed on the elongate member.

In Example 36, the subject matter of any one or more of Examples 33-35optionally includes sensing one or more motion parameters of theelongate member during implantation, and robotically controlling theexternal positioning unit to propel the cochlear implant according tothe sensed one or more motion parameters.

The systems, devices, and methods discussed in this document may improvethe technological field of robotic surgery, particularly roboticallyassisted implantation of an implant or prosthesis. For example, when thesystems or methods discussed herein are used in hearing-preservationcochlear implant surgery, the robotic motion control of the cochlearimplant and/or guide sheath may reduce the mechanical forces imposed onthe delicate cochlear structure such as basilar membrane and organ ofCorti, thereby minimizing the risk of trauma on the undamaged structuresuch as at the apical cochlea. This may ultimately better preservepatient residual natural hearing. Compared to manual insertion andsteering of a cochlear implant, the robotically assisted cochlearimplantation may allow more people with disabling hearing loss to hearbetter over their lifetimes.

The modular design of the robotically assisted implantation system, asdiscussed in this document, allows for easy replacement or interchangeof a particular module. This may not only improve the system reusabilityand efficiency, but may also reduce the cost of system maintenance. Forexample, the external positioning unit may be a single-use devicepositioned in a sterile surgical field or in contact with the patientduring an implantation surgery, and is disposable after surgery. Thecomputerized control unit may be positioned in a non-sterile field, suchas a control room, and can be reused with interchangeable externalpositioning units.

The external positioning unit is a non-implanted external device.Compared to a partially or completely implantable insertion device, theexternal positioning unit discussed herein may substantially reduce therisk of complications associated with surgical implantation, extraction,or replacement of otherwise partially or completely implantableinsertion device. The external positioning unit also has the advantageof easy trouble-shooting, maintenance, and replacement, thereby reducingcost of the system and the procedure. As to be discussed in thefollowing, the external positioning unit may have a small size withlimited mechanical and electrical parts, thus making it flexible forexternal fixation to a patient.

This summary is intended to provide an overview of subject matter of thepresent patent application. It is not intended to provide an exclusiveor exhaustive explanation of the disclosure. The detailed description isincluded to provide further information about the present patentapplication. Other aspects of the disclosure will be apparent to personsskilled in the art upon reading and understanding the following detaileddescription and viewing the drawings that form a part thereof, each ofwhich are not to be taken in a limiting sense.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments are illustrated by way of example in the figures ofthe accompanying drawings. Such embodiments are demonstrative and notintended to be exhaustive or exclusive embodiments of the presentsubject matter.

FIG. 1 illustrates, by way of example and not limitation, a roboticallyassisted implantation system and portions of an environment in which therobotically assisted implantation system may operate.

FIG. 2 illustrate, by way of example and not limitation, a block diagramof a power system that provides driving force and motion to the externalpositioning unit to propel and position an implant.

FIGS. 3A-3C illustrate, by way of example and not limitation, diagramsof external positioning units each coupled to an elongate member of animplant.

FIGS. 4A-4C illustrates, by way of example and not limitation,disengagement means for separating implant introducer sheath from theelongate member of an implant.

FIG. 5 illustrates, by way of example and not limitation, a portion ofan external positioning unit configured to enable manual control overthe motion of the implant.

FIG. 6A illustrates, by way of example and not limitation, a blockdiagram of a portion of a control system for robotically assisteddelivery and positioning of an implant.

FIG. 6B illustrates, by way of example and not limitation, a blockdiagram of a portion of a control system for robotically controllingdelivery and positioning of an implant using real-time feedback.

FIG. 7 illustrates, by way of example and not limitation, a method fordelivering and positioning an implant into a target implantation site ofa patient via an external, non-implantable robotically controlledimplantation system.

FIG. 8 illustrates, by way of example and not limitation, a method forsensor-based robotic control of a cochlear implant.

FIG. 9 illustrates, by way of example and not limitation, a method forsensor-based and measurement-based real-time control of implant deliveryand positioning.

FIGS. 10A-10B illustrate, by way of example and not limitation, aportion of an external positioning unit configured to deliver andposition a guide sheath and an implantable electrode.

FIG. 11 illustrates, by way of example and not limitation, a method forreal-time control of implant and guide sheath delivery and positioning.

FIGS. 12A-12C illustrate, by way of example and not limitation, diagramsof different views of a portion of an external positioning unit.

FIGS. 13A-13B illustrate, by way of example and not limitation, diagramsa portion of an external positioning unit coupled with a guide sheath.

FIG. 14 illustrates, by way of example and not limitation, a diagram ofan external positioning unit mounted on an adjustable arm.

DETAILED DESCRIPTION

In the following detailed description, reference is made to theaccompanying drawings which form a part hereof, and in which is shown byway of illustration specific embodiments in which the invention may bepracticed. These embodiments are described in sufficient detail toenable those skilled in the art to practice the invention, and it is tobe understood that the embodiments may be combined, or that otherembodiments may be utilized and that structural, logical and electricalchanges may be made without departing from the spirit and scope of thepresent invention. References to “an”, “one”, or “various” embodimentsin this disclosure are not necessarily to the same embodiment, and suchreferences contemplate more than one embodiment. The following detaileddescription provides examples, and the scope of the present invention isdefined by the appended claims and their legal equivalents.

Disclosed herein are systems, devices, and methods for roboticallyassisted implantation of an implant in a patient. The present system maybe implemented using a combination of hardware and software designed toprovide precise control of implant movement, such as insertion of acochlear implant and/or guide sheath during a hearing-preservationcochlear implant surgery. The system includes an external positioningunit configured to engage the implant, and a control consolecommunicatively coupled to the external positioning unit. The controlconsole may have a user interface that enables a user to input motioncontrol instructions. The control console may generate a motion controlsignal, according to a specific motion control instruction, to controlthe external positioning unit to propel the implant into a targetimplant site.

Although the discussion in this document focuses on cochlear implant,this is meant only by way of example and not limitation. It is withinthe contemplation of the present inventors, and within the scope of thisdocument, that the systems, devices, and methods discussed herein may beconfigured for robotically delivering, steering, positioning, orextracting various types of implants or prosthesis as well as associatedinstruments. By way of non-limiting examples, the implants may includeleads, catheter, guidewire, guide sheath, or other mechanical orelectrical devices. The implants may be designed for temporary orpermanent implantation. The implants may be used for medical diagnosisof a disease or other conditions such as diagnostic catheters, or fortherapeutic purposes of cure, mitigation, treatment, or prevention ofdisease, such as implantable electrodes for stimulating cardiac, neural,muscular, or other tissues. In addition to new implantation, thesystems, devices, and methods discussed herein may also be used tosurgically reposition or replace an existing implant.

FIG. 1 illustrates, by way of example and not limitation, a roboticallyassisted implantation system 100 and portions of an environment in whichthe system 100 may operate. The robotically assisted implantation system100 may include an external positioning unit 110 and a control console120. The robotically assisted implantation system 100 may additionallyinclude a power system 130. The robotically assisted implantation system100 may engage an implant 140, and robotically deliver and position theimplant 140 into a target implantation site of a patient 101.

The implant 140 may include an elongate member 141. The elongate member141 may be an integral part of the implant 141, such as a tubularimplant body or an elongate shaft. Examples of such an implant mayinclude an implantable lead or catheter. Alternatively, the elongatemember 141 may be a part of a delivery system detachably coupled to theimplant. Examples of such an implant may include a guidewire or anintroducer that may snatch an implant at a particular location, such asat a distal portion of the elongate member 141. The external positioningunit 110 may propel the elongate member 141, thereby transporting theattached implant to a target implantation site. Once the implant hasreached and been securely positioned at the target implantation site,the elongate member 141 may be disengaged from the implant, and theexternal positioning unit 110 may retract the elongate member 141 awayfrom the patient 101.

By way of example and not limitation, the implant 140 may include acochlear implant for treating hearing loss through electrostimulation ofa specified cochlea region. The cochlear implant, as illustrated in FIG.1, may include an implantable stimulator 143 and the elongate member 141with an electrode array such as disposed at distal portion 142 of theelongate member 141. The implantable stimulator 143, which may beimplanted under the scalp, can generate electrical impulses, and deliverthe electrical impulses to the electrode array through conductors in theelongate member 141. The electrode array may be surgically inserted intoand positioned at the target cochlear site. In patients with impairedhigh-frequency hearing function but preserved low-frequency hearingfunction, a short electrode array of the implant may be positioned atthe outer or basal cochlear region to deliver electrostimulation thereinto restore high-frequency hearing function.

As discussed in further detail below, the implant 140 may be deliveredthrough a guide sheath, which is alternatively or additionallycontrolled by the external positioning unit 110. In some examples, theexternal positioning unit 110 includes separate structures to control aguide sheath separately from the implant 140. In other examples, theguide sheath may be positioned initially by the external positioningunit 110, and the implant 140 implanted through the previouslypositioned guide sheath. In this example, the implant 140 can becontrolled by the external positioning unit 140 once the guide sheath isin place.

The external positioning unit 110 is a non-implanted external device.This may substantially reduce the risk of complications associated withsurgical implantation of an otherwise implantable implant insertiondevice. The external positioning unit 110 may include a coupling unit111 configured to interface with the elongate member 141 of the implant,and frictionally move the elongate member 141 to a specific direction(e.g., forward for implant insertion, or reverse for implantextraction), at a specific rate, or for a specific distance relative toa reference point such as the interface between the coupling unit 111and the elongate member 141. Examples of the coupling unit 111 mayinclude a leadscrew, a clamp, a set of rotors, or a rack and pinionarrangement, among other coupling mechanisms. The coupling unit 111 maycompress against at least a portion of the elongate member 141 toproduce sufficient friction between the coupling unit 111 and theelongate member 141. In some examples, the coupling unit 111 may includeadjustable couplers for reversible or interchangeable connection betweenthe external positioning unit 110 and the elongate member 141. In theevent of implant exchange or replacement, the coupling unit 111 may beadjusted to release the compression on the elongate member 141 of anexisting implant, which may be then removed from the externalpositioning unit 110. A new implant with an elongate member may bereloaded and engaged into the external positioning unit 110. Theexternal positioning unit 110 need not be removed and may remain inplace during implant replacement. Examples of the coupling unit 111 arediscussed below, such as with references to FIGS. 3A-3C. Examplesincluding positioning of a guide sheath are further discussed inreference to FIGS. 3D-3E.

The external positioning unit 110 is configured to be stably attached tothe patient, or to an object at the patient's immediate environment suchas the surgical table. In an example, the power system 130 may beseparated from, and external to, the external positioning unit 110. Theexternal positioning unit 110 may be a compact, lightweightmicromechanical device suitable for direct attachment to the patient,such as on the patient head during a cochlear implant surgery, whilemaintaining sufficient stability during the implantation. The externalpositioning unit 110 may be sized and shaped to facilitate patientattachment. In an example, the external positioning unit 110 may have acurved exterior contact surface that conforms to the contour of a bodypart of the patient 101, such as a head region. In an example, theexternal positioning unit 110 may include a fixation member to allow fordetachable affixation of the external positioning unit 110 to thepatient 101. The fixation may be invasive fixation that involvesincision of the skin and penetration of subcutaneous tissue. Examples ofthe fixation member may include one or more of a screw, a pin, a nail, awire, a hook, a suture, or a magnet within the external positioning unit110 coupled to one or more magnetic screws or pins affixed to the bodypart of the patient 101. In an example, the fixation member may includeone or more of self-drilling screws, self-tapping screws, orself-piercing screws, such that no pilot hole needs to be drilled at theaffixation site prior to screw installation. Alternatively, the fixationmay be non-invasive fixation with the use of non-invasive clamps orholding devices that prevent movement relative to the patient 101. Insome examples, the external positioning unit 110 may be affixed to atleast a portion of the implant 140, such as the implantable stimulator143. In an example, the affixation may be detachable. By way ofnon-limiting example, the affixation means may include hooks, clamps, ormagnets, among other direct or indirect holding members to preventrelative motion between the external positioning unit 110 and theimplant 140. In an example, the external positioning unit 110 may bemagnetically affixed to the implantable stimulator 143 which has amagnet within. In various examples, the implant 140 may includecommunication coils for data communication with the external positioningunit 110 and the control module 120. The magnetic coupling between theexternal positioning unit 110 and the implant 140 as discussed hereinmay allow the communication coils within the implant 140 to be alignedwith communication antenna coils within the external positioning unit110 to communicate, receive, or transmit data to and from the underlyingimplant 140, such as for transmitting electrophysiological data acquiredfrom the patient 101.

The contact surface of the external positioning unit 110 may beprocessed to improve stability during the implant advancement procedure.In an example, the external positioning unit 110 may have an exteriorsurface with a rough finish, such as ridges, corrugates, teeth, or othercoarse surface textures. Additionally or alternatively, the externalpositioning unit 110 may have one or more gripping elements configuredto frictionally bond the external positioning unit 110 to a body part ofthe patient 101. The gripping elements may be distributed on a portionof the exterior surface. Examples of the gripping elements may includepenetrators such as spikes, pins, or barbs protruding from the exteriorsurface. When the external positioning unit 110 is pressed and heldagainst the attachment region (e.g., patient head), the rough surface orthe gripping elements may provide sufficient friction or gripping forceto securely hold the external positioning unit 110 in place relative tothe patient 101 during the implantation advancement.

The control console 120 may include a dedicated hardware/software systemsuch as a programmer, a remote server-based patient management system,or alternatively a system defined predominantly by a controller softwarerunning on a standard personal computer. The control console 120 mayrobotically control the coupling unit 111 to propel the elongate member141 at specific rate, to a specific direction, or for a specificdistance, or at a specific maximum force, thereby delivering andpositioning the implant 140, such as an electrode array of a cochlearimplant, at the target implantation site of the patient 101. The controlconsole 120 may additionally receive information acquired by sensorsdisposed on the motor system 130 or the external positioning unit 110,as to be discussed in the following. The control console 120 may alsoreceive measurement data from external systems that can be directlyrelated to implant position. The control console 120 can utilize suchmeasurement data (e.g., electrophysiological measurements) for closedloop control of implant positioning. In addition to sensing motionparameters, electrophysiological measures can be linked to systemcontroller through software interfaces or means for inputting to controlsystem in real-time measures such as electrocochleography (ECoG), neuralresponse telemetry, cochlear response telemetry, or auditory brainstemresponses (ABRs) recordings from either the cochlear implant or otherECoG recording system or method.

The control console 120 may control the external positioning unit 110via a power system 130. The power system 130 includes a motor that maygenerate driving force and motion, and a power transmission unit totransmit the driving force and motion to the coupling unit 111 toactuate the motion of the elongate member 141. The power transmissionunit may include one or more of chains, belts, gears, or shaftcouplings, among others. In an example, the power system 130 may beseparated from the external positioning unit 110 and the control console120, and coupled to the coupling unit 111 via a connection 152. Theconnection 152 may be a part of the transmission unit. In anotherexample, the power system 130 may be at least partially included in orassociated with the external positioning unit 110. In yet anotherexample, the power system 130 may be at least partially included in orassociated with the control console 120. Examples of the power system111 are discussed below, such as with references to FIG. 2.

The control console 120 may include a user interface module 121 and acontroller circuit 122. The user interface module 121 may include a userinput module 125 and an output module 126. The user input module 125 maybe coupled to one or more input devices such as a keyboard, on-screenkeyboard, mouse, trackball, touchpad, touch-screen, or other pointing ornavigating devices. In some example, the user input module 125 may beincorporated in a mobile device communicatively coupled to the controlconsole 120, such as a handheld device. The user input module 125 may beconfigured to receive motion control instructions from a user. Themotion control instructions may include one or more target motionparameters characterizing desired movement of the elongate member 141 ofthe implant. For example, the target motion parameters may definemaximum values or value ranges of the motion parameters. Examples of thetarget motion parameters may include a target movement rate, a targetmovement direction or orientation, a target movement distance, a targetposition of a distal end of the elongate member, or a target amount offorce imposed on the elongate member 141. The movement of the implantmay be activated at intervals of a predetermined step size. In anexample of implantation of a cochlear implant, the target movement rateis approximately at 100-micron intervals. In an example, the targetmovement distance is approximately 1-35 millimeters. The motion controlinstructions may include a pre-determined implant delivery protocol thatdefines target values of a plurality of motion parameters. The implantdelivery protocols are designed to ease the programming of the motioncontrol, and to minimize peri-surgical tissue trauma or damage to theimplant.

The user interface module 121 may allow a user to select from a menu ofmultiple implant delivery protocols, customize an existing implantdelivery protocol, adjust one or more motion parameters, or switch to adifferent implant delivery protocol during the implant deliveryprocedure. The control console may include a memory circuit 124 forstoring, among other things, motion control instructions. In an example,one of the delivery protocols may include use intraoperative ECoGmeasures such as cochlear microphonics (CM), auditory nerve neurophonics(ANN) that can reflect immediate changes in the cochlear mechanics andinsertion trauma pre-, during-, and post-insertion of the electrodearray. Use of discussed in further detail below in reference to FIGS. 6and 9

The output module 126 may generate a human-perceptible presentation ofinformation about the implant delivery control, including theprogrammable motion control parameters, and the motion controlinstructions provided by the user. The presentation may include audio,visual, or other human-perceptible media formats, or a combination ofdifferent media formats. The output module 126 may include a displayscreen for displaying the information, or a printer for printing hardcopies of the information. The information may be displayed in a table,a chart, a diagram, or any other types of textual, tabular, or graphicalpresentation formats. Additionally or alternatively, the output module126 may include an audio indicator such as in a form of beeps, alarms,simulated voice, or other sounds indicator.

The robotically assisted implantation system 100 may comprise one ormore sensors configured to sense one or more motion parameters of theimplant during implantation. The output module 126 may generate ahuman-perceptible presentation of the sensor feedback, including one ormore parameters on the position of the implant, motion of the implant,or the force or friction applied to the implant motion. This allows asurgeon to monitor in real time the progress of the implantation, andadjust the motion control as needed. The presentation may includereal-time visual or audible notification with specified patternscorresponding to different types of events encountered duringimplantation. In an example, the output module 126 may include a visualindicator, such as a light emitting diode (LED) or an on-screenindicator on the display screen. A specific LED color or a specificblinking pattern may signal to the user a successful positioning of theimplant at the target implantation site. A different LED color or adifferent blinking pattern may alert an excessive force imposed on theimplant due to unintended tissue resistance during the implantadvancement. The output module 126 may additionally or alternativelyinclude an audio indicator, such as a beep with a specific tone, aspecific frequency, or a specific pattern (e.g., continuous,intermittent, pulsed, sweep-up, or sweep-down sound). In an example, abeep or an alarm with a specific tone or pattern may signal to the usersuccessful positioning of the implant at the target implantation site. Abeep or an alarm with a different tone or different pattern may alert anexcessive force imposed on the implant. In an example, the beep or thealarm may go off continuously as the sensor senses the implantapproaching the target site. The sound frequency or the pulse rate ofthe beep or the alarm may increase as the implant gets closer andfinally reaches the target site. In an example, the frequency of thebeep or the alarm may correspond to a rate of motion, such as soundingfor every one millimeter of motion. Audible feedback on the motionparameters may be advantageous in that the surgeon may be notified inreal time the implantation status or events encountered without the needto look away from surgical field. This may assist surgeon with enhancedsurgical precision and patient safety. In some examples, the audible orvisual sensor feedback may signal to the user that the sensed implantposition, motion, or for has exceeded the programmed target or maximumparameter values.

The controller circuit 122 may be configured to generate a motioncontrol signal according to the motion control instructions provided bythe user via the user input module 125. The motion control signal maycontrol the power system 130 to regulate one or more motion parametersof the elongate member 141. Examples of the motion parameters mayinclude a movement rate, a movement direction or orientation, a movementdistance, a position of a distal end of the elongate member, or anamount of force imposed on the elongate member 141, among others. In anexample where the power system 130 is separated from and external to thecontrol console 120, the controller circuit 122 may remotely control thepower system 130 via a communication circuit 123. The communicationcircuit 123 may transmit the motion control signal to the power system130 via the communication link 151. The communication link 151 mayinclude a wired connection including universal serial bus (USB)connection, or otherwise cables connecting the communication interfaceson the control console 120 and the power system 130. The communicationlink 151 may alternatively include a wireless connection, such as aBluetooth protocol, a Bluetooth low energy protocol, a near-fieldcommunication (NFC) protocol, Ethernet, IEEE 802.11 wireless, aninductive telemetry link, or a radio-frequency telemetry link, amongothers.

In some examples, the controller circuit 122 may control the motion ofthe elongate member 141 further according to information about patientmedical history or disease state received via the user input module 125,or stored in the memory circuit 124. In an example of cochlear implant,information about patient tonotopic hearing loss pattern. The tonotopichearing loss pattern represents a spatial distribution of frequencysensitivity along the axis of the cochlea length. Based on the input ofthe patient tonotopic hearing loss pattern, the controller circuit 122may automatically program one or more motion parameters, such as theelectrode array insertion distance. For example, for a patient with atonotopic pattern of high-frequency insensitivity and preserved low tomedium-frequency sensitivity, a shorter cochlear implant insertiondistance is indicated. The electrode array of the cochlear implant maybe positioned and electrically stimulate the outer or basal cochlearregion to restore high-frequency hearing. Conversely, for a patient witha tonotopic pattern of high-frequency insensitivity as well asdeteriorated low to medium-frequency hearing, a longer insertiondistance is indicated. The electrode array of the implant may bepositioned to stimulate a wider cochlear region that covers the outer orbasal region as well as certain inner or apical cochlear region. Thetailoring of the implant motion parameters (such as the implantinsertion distance) based patient tonotopic pattern enables anindividualized treatment regimen to achieve improved therapy outcome,and can best fit a patient's evolving hearing loss. It may expandcandidacy range, qualifying more people for cochlear implant therapy.

In an example, the controller circuit 122 may control the motion of theelongate member 141 further according to ECoG measures received. Areal-time link to ECoG measure during implant insertion enablesnotification of potential physiological injury to intracochlearstructures, such as contact with the basilar membrane. If decreases orsignificant changes are recorded in ECoG measures, the controllercircuit 122 can provide immediate feedback to the surgeon, through theuser interface module 121, in the form of visual or audiblenotifications and a stop command may be sent to the system controller toprevent further implant motion. Optionally, the controller circuit 122can be programmed to automatically stop or reverse the insertion upondetection of certain ECoG measurement signatures. After the systemnotification to the user or automatic intervention, the surgeon mayadjust implant insertion trajectory or system motion parameters asneeded to avoid intracochlear damage or suboptimal electrode position orchoose to the override notifications via physical acknowledgementmechanism. After acknowledgment of warning notification, the stopfeedback is removed and the user may continue robotic-assisted insertionof the implant.

The external positioning unit 110 may include a manual control mechanismin addition to the robotic control of the coupling unit 111. The manualcontrol mechanism may bypass or override the robotic motion control ofthe implant 140. Examples of the manual control mechanism may include adial turn, a screw, or direct insertion technique. The output module 126may enable a user to selectably enable a robotic mode for roboticallyassisted motion control via the power system 130, or a manual overridemode for manual motion control of the elongate member 141.Alternatively, an operation on the manual control mechanism mayautomatically withhold or disable the robotic motion control of theelongate member 141. Examples of the manual control of the externalpositioning unit are discussed below, such as with references to FIG. 5.

Portions of the control console 120 may be implemented using hardware,software, firmware, or combinations thereof. Portions of the controlconsole 120 may be implemented using an application-specific circuitthat may be constructed or configured to perform one or more particularfunctions, or may be implemented using a general-purpose circuit thatmay be programmed or otherwise configured to perform one or moreparticular functions. Such a general-purpose circuit may include amicroprocessor or a portion thereof, a microcontroller or a portionthereof, or a programmable logic circuit, or a portion thereof. Forexample, a “comparator” may include, among other things, an electroniccircuit comparator that may be constructed to perform the specificfunction of a comparison between two signals or the comparator may beimplemented as a portion of a general-purpose circuit that may be drivenby a code instructing a portion of the general-purpose circuit toperform a comparison between the two signals.

FIG. 2 illustrate, by way of example and not limitation, a block diagramof a power system 230 that provides driving force and motion to theexternal positioning unit 210 to deliver and position an implant. Thepower system 230 may be an embodiment of the power system 130 of therobotically assisted implantation system 100 as illustrated in FIG. 1.The power system 230 may provide a one-degree of freedom, ormultiple-degrees of freedom, control over the elongate member 141 of theimplant.

The power system 230 may include one or more electric motors 231 eachcoupled to respective power transmission units 232. The one or morepower transmission units 232 are each coupled to respective couplingunits 211 in the external positioning unit 210, which is an embodimentof the external positioning unit 110 as illustrated in FIG. 1. The oneor more electric motors 231 may be electrically coupled to a powersource 233. In an example, the power source 233 may include arechargeable power source, such as a rechargeable battery or asupercapacitor. The rechargeable power source may be charged wirelesslyby a portable device such as a handheld device with circuitry configuredto transfer energy to the rechargeable power source throughelectromagnetic induction.

The one or more electric motors 231 may be of the same or differenttypes of motors. Examples of the electric motors 231 may include steppermotors, direct current (DC) motors, piezo electric motors, ultrasonicmotors, or linear motors, among others. The one or more electric motors231 may each be coupled to a transponder 234 that may receive motioncontrol signals from the control console 120 via the communication link151. The control console 120 may generate respective motion controlsignal for each of the electric motor 231 according to the motioncontrol instructions provided by the user. In an example, a user mayindependently program (by inputting the motion control instructions) andcontrol the operation of each of the electric motors 231, such as viathe user input module 125. The motion control signal specify theconfigurations and input voltage or current to the respective electricmotor 231, which may generate the desired torque, speed, or rotationdirection.

In response to the received motion control signal, the one or moreelectric motors 231 may generate respective driving force and motionthat control various motion parameters of the elongate member 141 of theimplant via the power transmission unit 232. The power transmissionunits 232 may adjust the speed or torque output from the motors, and todeliver specific output to the respective coupling units 211. Examplesof the power transmission units 232 may include spur gears, helicalgears, planetary gears or gearhead, worm gears, miniature pulleys, ortiming belts, among others.

By way of example and not limitation, and as illustrated in FIG. 2, theelectrical motors 231 may include at least a first electric motor 231Aand a second electric motor 231B. The first electric motor 231A maygenerate driving force and motion, transmitted to the first couplingunit 211A via the first power transmission unit 232A, to control one ormore parameters associated with a motion along a first orientation, suchas a translational motion. Examples of the translational motionparameters may include movement rate, direction, distance relative to areference point, a position of a distal end of the elongate member, oran amount of axial force applied to the elongate member. The secondelectric motor 231B may generate driving force and motion that istransmitted to the second coupling unit 211B via the second powertransmission unit 232B, and control one or more parameters associatedwith a motion along a second orientation, such as a rotational motion.Examples of the rotational motion parameters may include angularposition, angular displacement, angular velocity, or an amount oflateral or rotational force applied to the elongate member. The firstand second electrode motors, along with the respective powertransmission units and the coupling units in the external positioningunit, may provide a flexible and precise control of the motion of theimplant on multiple degrees of freedom. This may allow for optimalpositioning of the implant at the target implantation site, such asplacement of cochlear implant electrode array in close proximity toauditory nerve cells and neurons.

One or more sensors may be configured to sense information aboutposition and motion of the implant during implantation, such as a sensor235 in the power system 230, or a sensor 212 in the external positioningunit 210. In an example, one or more linear or rotary encoders may beattached to the electric motor 231, the power transmission unit 232, orthe coupling units 211 to detect the information about position of theimplant. In another example, one or more Hall effect sensors may beintegrated in the electric motor 231. In yet another example, one ormore optional sensors may be attached to the coupling unit 211. In someexamples, the sensor 235 or the sensor 212 may include capacitivesensors configured to detect implant motion.

In addition to or in lieu of the motion and position sensing, the sensor235 or the sensor 212 may include force sensors to sense a parameterindicative of force or friction imposed on the implant during theimplant advancement, such as axial, lateral, or radial forces when thecochlear implant interacts with cochlea wall and surrounding tissues.Examples of the force sensors may include resistors, capacitive sensors,piezoelectric material, or a strain gauge, among others. In an example,the force may be indirectly sensed by measuring the current supplied tothe electric motor 231. The current measurement may be transmitted tothe control console 120, where it is converted to the force (or torque)using the torque-current curve predetermined and stored in the memorycircuit 124.

The information acquired by the sensors 235 and the sensors 212 may beforwarded to the control console 120 via the communication link 151. Thesensor information may be displayed or otherwise presented in a specificmedia format in the output module 126. In an example, the externalpositioning unit 210 may include an indicator 213 coupled to the sensor212. The indicator 213 may produce a visual or audio notification inresponse to the sensed sensor signal satisfies a specific condition. Inan example, the indicator 213 may include a light emitting diode (LED)that may be turned on when the sensed sensor signal indicates theimplant reaches the target implantation site. In some examples, theindicator 213 may include a plurality of LEDs with different colors ordifferent pre-determined blinking patterns. The LED colors or theblinking patterns may correspond to various events encountered duringthe implantation procedure.

The control console 120 may generate and modify the motion controlsignal based on user input of motion control instructions to control themotion of the elongate member of the implant. Alternatively, the controlconsole 120 may automatically adjust the motion control according to thesensed motion parameters. In an example, if the sensed force imposed onthe implant exceeds a threshold value, the control console 120 mayautomatically halt the ongoing motion of the implant or reduce the speedof motion. An alert may be generated and presented on the output module126. This may be a programmable safety mechanism to prevent unintendedtissue trauma or damage to the implant. If the implant movement distancehas reached a pre-determined target movement distance, the controlconsole 120 may automatically withhold the motion of the implant.

FIGS. 3A-3C illustrate, by way of example and not limitation, diagramsof external positioning units 300A and 300B each coupled to an elongatemember 301 of an implant. The elongate member 301, which is anembodiment of the elongate member 141, may be a part of a cochlearimplant that includes an electrode array disposed on the elongate member301. The external positioning units 300A and 300B are embodiments of theexternal positioning unit 110 as illustrated in FIG. 1.

The external positioning unit 300A illustrated in FIG. 3A includes ahousing 310 that encloses electro-mechanical components interconnectedto engage the elongate member 301 and robotically deliver and positionthe implant attached to the elongate member 310 into a targetimplantation site. The housing 310 may include an entrance and an exitports to feed the elongate member 310 through the external positioningunit 300A The external positioning unit 300A may include at least tworollers, such as a drive wheel 320 and an idler wheel 330, which areembodiments of the coupling unit 111 or 211. The drive wheel 320 and theidler wheel 330 are arranged and configured to engage at least a portionof the elongate member 301. The engagement of the elongate member 301may be through compression between respective radial outer surfaces ofthe drive wheel 320 and an idler wheel 330.

The drive wheel 320 may be coupled via a bearing to an axle that issecurely attached to the housing 310, such that the drive wheel 320 mayrotate on the axle without lateral movement relative to the housing 310.The drive wheel 320 may be coupled to an electric motor 342 via a powertransmission unit 344. The electric motor 342, which is an embodiment ofone of the electric motor 231, may generate driving force and motionaccording to a motion control signal provided by the control console120. The electric motor 231 may be coupled to the power transmissionunit 344, which may be an embodiment of one of the power transmissionunit 232. The power transmission unit 344 may include gears, pulleys, ortiming belts that adjust a speed or torque of the motors. In an exampleas illustrated in FIG. 3A, the power transmission unit 344 may include aworm gear set 344 comprising a worm gear, and a shaft securely coupledto a gearhead of the electric motor 342. Depending on the motion controlsignal input to the motor 342, the power transmission unit 344 may driverotation of the drive wheel 320, which in turn propels the implant to aspecific direction (e.g., forward or backward) or at specific rate.

The idler wheel 330 may be coupled to a biasing system that includes atorsion spring 352, a pivot arm 354, and a spring bias 356interconnected to support the second wheel 330 and to provide lateralcompression against the drive wheel 320. The torsion spring 352 mayproduce spring tension relayed to the second wheel 310 via the pivot arm354, and compress against the drive wheel 320 to generate adequatefriction on the elongate member 301 between the drive wheel 320 and theidler wheel 330. Because the idler wheel 330 is held in place by thebiasing system rather than being affixed to the housing 310, the idlerwheel 330 may move laterally relative to the housing 310. This may allowfor accommodating implants with elongate members of a range of diametersor cross-sectional shapes, while maintaining sufficient friction on theelongate member for desirable movement. In an example, a user maymanually bias the torsion spring 352 and move the idler wheel 330 awayfrom the drive wheel 320, thereby release the compression and open thespace between the drive wheel 320 and the idler wheel 330. The surgeonmay remove the elongate member 301 from the external positioning units300A, or load another implant with an elongate member into the externalpositioning units 300A.

In some examples, the radial outer surface of the drive wheel 320 may becoated with a frictious material, such as a layer of silicone rubber,polymer, or other composite materials. Additionally or alternatively,the radial outer surface of the drive wheel 320 may be mechanicallytextured to have a rough and corrugated surface. The frictious materiallayer or the corrugated surface finish of the radial outer surface ofthe drive wheel 320 may increase the friction and prevent the elongatemember 301 from slipping on the drive wheel 301 during frictionalmotion. The radial outer surface of the idler wheel 330 may similarly becoated with the frictious material or have a rough surface finish.

FIG. 3C illustrates a cross-sectional view 300C of the drive wheel 320and the idle wheel 330 with the elongate member 301 engagedtherebetween. In an example as illustrated in 300C, the elongate member301 has a cylindrical shape or otherwise has a convex cross-sectionalprofile. The radial outer surface 321 of the drive wheel 320 and theradial outer surface 331 of the idle wheel 330 may each have a radiallyconcave profile to allow for secure engagement of the elongate member301. The concavity of the concave profile, which quantifies a degree ofthe concave surface, may be determined based on the geometry such as thediameter of the elongate member 301.

The drive wheel 320 and the idler wheel 330 illustrated in FIG. 3A maygenerate one-degree of freedom of movement, such as a translationalmotion. In some examples, the external positioning unit 300A may includeadditional wheels or gear sets arranged and configured to translate theforce and motion generated from the motor 342 into multiple-degrees offreedom movement, as previously discussed with reference to FIG. 2. Inan example, the external positioning unit 300A may include a gear set totranslate the motor motion into a rotational motion of the elongatemember 301 around its axis. The gear set may include a geared drivewheel coupled to a worm gear coaxially disposed along, and detachablycoupled to, a portion of the elongate member 301. The geared drivewheel, when driven to rotate by the motor 342 and the power transmissionunit 344, may drive rotation of the worm gear, which in turn cause therotation of the elongate member 301 around its axis.

The drive wheel 320 and the spring-biased idler wheel 330 are an exampleof the coupling unit by way of illustration and not limitation. Analternative coupling unit may include a geared drive wheel coupled to animplant carrier. The carrier may include an adapter housing placed overand securely hold the elongate member of the implant. The adapterhousing may be made of silicone or metal. The carrier may have a lineargear arrangement with teeth configured to engage with the geared drivewheel. The geared drive wheel and the linear gear of the carrier maythus have a rack-and-pinion arrangement, where the geared drive wheel(the pinion) applies rotational motion to the linear gear (the rack) tocause a linear motion relative to the pinion, which in turn may linearlymove the elongate member held within the adapter housing of the carrier.

One or more sensors may be attached to the internal components of theexternal positioning unit 300A, such as the electric motor 342, thepower transmission unit 344, the drive wheel 320, or the spring-biasedidler wheel 330. Examples of the sensors may include an encoder or aHall effect sensor. The sensors may sense the location or motion of theelongate member 301, or the force or friction applied to the elongatemember 301. In an example, a first sensor may be attached to the motor342 to detect the motion of the motor (which indicates the position ormotion of the elongate member 301), and a second sensor may be attachedto the idler wheel 330 to detect the motion of the idler wheel (whichalso indicates the position or motion of the elongate member 301). Thefirst and second sensors may jointly provide a double check of theimplant's position, and can more reliably detect any slippage that mayoccur between the drive wheel 320 and the elongate member 301. Forexample, if the motor 342 functions normally but the elongate member 301slips on the drive wheel 320, the first position sensor on the motorwould indicate implant movement, but the second position sensor on theidler wheel 330 would indicate no movement or irregular movement of theimplant. The control console 120 may include circuitry to detect adiscrepancy between the position or motion feedbacks from the first andsecond sensors. If the discrepancy exceeds a specific threshold, thecontrol console 120 may generate an alert of device fault and presentedto the user via the output module 126, or automatically halt theimplantation procedure until the user provides instructions to resumethe procedure.

The external positioning unit 300A may include a sheath 360. The sheath360 may be attached to a distal end of the housing 310, and extend to asurgical entrance of the target implantation site. The elongate member301 may be flexible and prone to twisting, entanglement, or buckling.The sheath 360 may at least partially enclose the elongate member 301 toprovide resilient support to the elongate member 301 of the implant,thereby keeping the implant on track between the housing 310 and thesurgical entrance of the target implantation site. It may also protectelectronics such as an electrode array positioned on the elongate member301 and the conductors inside the elongate member 301.

The sheath 360 comprises a flexible tube whose dimensions maysubstantially match the elongate member 301. For example, the diameterof the tube may be slightly greater than the diameter of the elongatemember 301, such that the flexible tube may provide desired rigidity tothe elongate member 301 inside; while at the same does not produce unduefriction between the elongate member 301 and the interior surface of thetube. To decrease friction produced by the motion of the elongate member301 relative to the tube during implantation, the sheath 360 may bepre-lubricated with a biocompatible and sterilizable lubricant.Alternatively or additionally, the interior surface of the tube may betreated with Polytetrafluoroethylene (PTFE) or linear longitudinalridges to allow for smooth sliding of the elongate member 301 inside thetube.

The distal end of the sheath 360 may be fixed or reversibly stabilizedat a designated position of the surgical opening of the implantation. Inan example of cochlear implant, the distal end of the sheath 360 may bestabilized at the cochlea round window (RW) or cochleostomy site byclosely matching tube diameters to the RW niche or cochleostomydimensions. This would allow the sheath 360 to be compressed into the RWniche, or temporarily through the RW membrane. The sheath 360 may bemade of material with low friction, such as plastic or silicone rubber,and biocompatible for tissue contact and compatible with variousdisposable sterilization methods such as radiation (e.g., gamma,electron beam, or X-ray), or ethylene oxide gas treatment. The sheath360 may be detached from the implant once the implant is positioned atthe target site of implantation. Examples of the disengagement means forseparating the sheath 360 from the implant are discussed below, such aswith reference to FIGS. 4A-4C.

In some examples, the external positioning unit 300A may be affixed tothe patient or an object in the sterile field of surgery. The componentsinside the external positioning unit 300A, including the drive wheel320, the idler wheel 330, the idler wheel biasing system (including thetorsion spring 352, the pivot arm 354, and the spring bias 356), and thepower system (including the electric motor 342 and the powertransmission unit 344), may be made of materials that are bothbiocompatible and compatible with a specific sterilization method, suchas gamma or ethylene oxide. The electro-mechanical components may bemade of plastic such as Acrylonitrile-Butadiene-Styrene (ABS),Polycarbonate, Polyetheretherketone, or Polysulfone, among others. Theelectro-mechanical components may alternatively be made of metal such asstainless steel, cobalt chromium, or titanium, among others.

The external positioning unit 300B as illustrated in FIG. 3B has asimilar structure to the external positioning unit 300A, except that theelectric motor 342 is positioned outside the housing 310. The force andmotion generated from the electric motor 342 may be transmitted to thedrive wheel 320 via a flex rotating shaft 356 running between the motor342 and the external positioning unit 300B. In an example, the electricmotor 342 may be enclosed in standalone housing separated from theexternal positioning unit 300B and the control console 120. In anotherexample, the electric motor 342 may be included in or associated withthe control console 120. The flex rotating shaft 356 may be integratedwith a communication cable linking the external positioning unit 300Band the control console 120, such that a single cable exits thepositioning unit 300B. The communication cable may transmit the sensorfeedback on the position or motion of the elongate member 301, or theforces imposed on the elongate member 301 such as sensed by one or moresensors on the positioning unit 300B, such as illustrated in FIG. 2.

With the exclusion of the electric motor 342, the external positioningunit 300B may offer several benefits. The external positioning unit 300Bmay be a smaller, simpler, light-weighted, and low-cost micromechanicaldevice. As the electric motor 342 and associated electrical system areaway from direct patient contact and outside of the patient immediateenvironment, the external positioning unit 300B may offer an increasedpatient safety. The external positioning unit 300B may be for single usein a sterile surgical field, and is disposable after the surgery. Atleast due to its small size and lightweight, the external positioningunit 300B may be suitable for fixation on a patient as a stable platformfor advancing the implant.

FIGS. 4A-4C illustrates, by way of example and not limitation,disengagement means for separating implant introducer sheath 460A-460Cfrom the elongate member 301 of an implant when the implant ispositioned at the target site of implantation. The introducer sheath460A-460C are embodiments of the sheath 360 as illustrated in FIGS.3A-3B. The disengagement means may detach the elongate member 301 fromthe introducer sheath 46A-460C without imposing damaging forces on theimplant such as to prevent dislodgement of the implant from theimplantation site upon removal of the sheath 360. In ahearing-preservation cochlear implant surgery, for example, once anelectrode array of the cochlear implant has been positioned at a desiredcochlear region (e.g., the basal cochlea) for stimulating the auditorynerves therein, a surgeon may separate the introducer sheath 460A-460Cfrom elongate member 301 using the disengagement means without causedislodgement of the electrode array or any trauma to the nearby cochleartissue.

FIG. 4A illustrates an example of an introducer sheath 460A having across section 461 with a shape of a semi-circle or a minor arc, and anopen portion along its trajectory. The open portion may be sized suchthat the elongate member 301 stays stably embedded inside the sheath460A during implantation, and can easily be pulled out afterwards. Sucha sheath with an open portion may achieve a balance between the size ofthe open portion and the relative difference in durometers of the sheathand implant materials.

FIG. 4B illustrates an example of an introducer sheath 460B thatincludes two longitudinal halves running in parallel, such as a toppiece 462 and a bottom piece 463. The two longitudinal halves aredetachably affixed to each other. As illustrated in FIG. 4B, the top andbottom pieces 462 and 463 may each have a semi-circle shape (i.e.,180-degree arc). Alternatively, one piece may be shaped as a minor arc(i.e., less than 180 degrees) and the other shaped as a major arc (i.e.,greater than 180 degrees). The two longitudinal halves may be connectedwith a biocompatible and sterilization-resistant adhesive or sealant.The adhesive or sealant may have an adhesion strength sufficient to holdthe two longitudinal pieces together, and may be weakened under apulling stress. After the implant is being positioned at the desiredimplantation site, the two longitudinal halves may be disengaged fromeach other under pulling stress by a surgeon, thereby separating theelongate member 301 from the top and bottom pieces 462 and 463.

FIG. 4C illustrates an example of an introducer sheath 460C configuredas a peel-away sheath. The introducer sheath 460C may include dual knobsor release tabs 464 and 465 attached to the circumferential surface ofthe elongate member 301, such as at a distal portion of the elongatemember 301. The dual knobs or the release tabs 464 and 465 may be sizedand shaped to allow for a user, by using a surgical tool such asforceps, to peel away the introducer sheath 460C after the implant ispositioned at the target implantation site. The introducer sheath 460Cmay have linear perforations 466 on opposing longitudinal sides tofacilitate the tearing of the introducer sheath 460C into two opposingpieces.

FIG. 5 illustrates, by way of example and not limitation, a portion ofan external positioning unit 500 configured to enable manual controlover the motion of the implant. The external positioning unit 500, whichmay be an embodiment of the external positioning unit 110 or 210, mayinclude mechanics enclosed in a housing 310 attached to a base 550. Thebase 550 may be detachably affixed to the patient or an object on thepatient immediate environment via a fixation member 560 such as screws,pins, nails, wires, hooks, a suture, or a magnet, as discussed withreference to FIG. 1. Similar to the external positioning units 300A or300B as illustrated in FIGS. 3A-3B, the illustrated portion of theexternal positioning unit 500 comprises at least two rollers, includinga drive wheel 520 and an idler wheel 530 arranged and configured toengage at least a portion of the elongate member 301, such as throughcompression between respective radial outer surfaces of the drive wheel520 and an idler wheel 530. At least one roller, such as the drive wheel520, may be coupled to a manual drive wheel 510 via a transmission unit540. The transmission unit 540 may include a gear set such as a spurgear, or one or more of chains, belts, or shaft couplings, among others.The manual drive wheel 510 may be coupled an axle securely attached tothe base 550 or the housing 310 at a position such that a portion of themanual drive wheel 510 sticks outside the housing 310. A user maymanually access and rotate the manual drive wheel 510 around the axle,which in turn drives rotation of the drive wheel 520, and frictionallymove the elongate member 301 at a desired direction and speed.

In some examples, the manual motion control as in the externalpositioning unit 500 may be combined with the motorized motion controlin the external positioning unit 300A or 300B. The drive wheel 520 andthe idler wheel 530 may engage a first location of the elongate member301 to manually control the implant motion, and the drive wheel 320 andthe idler wheel 330 may engage a different second location of theelongate member 301 to robotically control the implant motion. Inanother example, a portion of the external positioning unit 500, such asthe manual drive wheel 510 and the coupled transmission unit 520, may beincorporated into the external positioning unit 300A or 300B and coupledto the drive wheel 320. The drive wheel 320 may be subject to both arobotic control through the motor 342 and the power transmission unit344, and a manual control through the manual drive wheel 510 and thecoupled transmission unit 520. The robotic control and the manualcontrol may be activated independently from each other. In an example,the user interface module 121 may enable a user to selectably enable arobotic mode for robotic motion control, or a manual mode for manualmotion control of the elongate member 301. In an example, the manualmode may take priority over the robotic mode, such that a manualrotation of the manual drive wheel 510 may automatically override therobotic motion control. The manual override function may be utilized asa fail-safe emergency stop in case there is a fault in the motor 342 orthe power transmission unit 344.

FIG. 6A illustrates, by way of example and not limitation, a blockdiagram of a portion of a control system 600 for robotically assisteddelivery and positioning of an implant. The control system 600 comprisesa control console 120 coupled with one or more peripheral devices forimplant motion control. The peripheral devices may include one or moreof a foot petal 610, or a handheld device 620. In an event that themotor and the power system are included within the external positioningunit, the one or more peripheral devices may be communicatively coupledto the external positioning unit to directly control the motor output.The one or more peripheral devices may be communicatively coupled to thecontroller circuit 122 included in the control console 120, such as viaa wired connection or a wireless communication link. Compared to thecontrol console 120, the peripheral devices may have smaller size,lighter weight, and more mobility, thereby may provide enhancedoperation flexibility. Some peripheral devices, such as a foot pedal,may be reusable. The materials need not be sterilizable or biocompatibleto the level at which the external positioning unit materials do.

The foot pedal 610 may provide the surgeon with the means to control themotion of the implant. The foot pedal may be positioned under thepatient table, accessible to the surgeon. The foot pedal 610 maycomprise a motion control input 611. In an example, the motion controlinput 611 may include two or more pedals for use to control lead motionat different directions, such as one pedal to activate forwardadvancement motion, and another pedal to activate retraction motion tofine-tune the implant position or for implant extraction. In anotherexample, the motion control input 611 may include two or more pedals foruse to control lead motion at different lead orientation, such as onepedal to control the translational motion, and another pedal to controlthe rotational motion, as previously discussed with reference to FIG. 2.In yet another example, the motion control input 611 may include onepedal used for controlling implant advancement, and another pedal usedfor resetting the current implant position (i.e., setting the currentposition to zero). If a retraction action is needed, this may be aninput on the control console 120, where the retraction command may begenerated from the control console 120. This would prevent accidentalretraction of the implant by stepping on the wrong pedal.

In some examples, each foot pedal may be incorporated with one or morecommand buttons or switches that are programmed for different functions,such as for controlling various motion parameters including motion rate,motion distance, or amount of force applied to the implant duringinsertion. In an example, different motion control actions maycorrespond to programmed duration when pedal is pressed and held, orpatterns of the pedal press (such as one press, double press, or acombination of short and long press). For example, a short press may setthe current implant position to zero (i.e., position reset), and a longpress (e.g., press and hold for at least three seconds) may advance theimplant. In an example, one press or button push may correspond to aspecific distance of movement, such as 100 micron during a cochlearimplantation procedure. In another example, the rate of insertion or thedistance of the movement may vary based on a degree of foot pedaldisplacement up to the maximum set insertion rate and distance asprogrammed by a user via the user interface module 121.

The handheld device 620 may include a motion control input 621, such asbuttons, switches, or other selection and activation mechanisms tocontrol one or more motion parameters of the implant. In some examples,the communication circuit 123 may be implemented inside the handhelddevice 620. In an example, the communication circuit 123 may communicatewith the external positioning unit 210 via a wireless communicationlink, including transmitting the motor control signal to the electricmotor 231, and receive sensor feedback from one or more sensors locatedat the power system 230 or the external positioning unit 210. Themobility of the handheld device may allow for enhanced reliability ofwireless communication. In some examples, the handheld device 620 mayinclude a charger circuit 622 for wirelessly charging a power source forpowering up the electric motor such as located inside the externalpositioning unit.

FIG. 6B illustrates, by way of example and not limitation, a blockdiagram of a portion of a control system for robotically controllingdelivery and positioning of an implant using real-time feedback. In thisexample, the control system 600 can optionally include an ECoG input630. The ECoG input 630 can supply ECoG measurement data in real-time tothe controller circuit 122. The ECoG input 630 can link the controlsystem 600 to ECoG measures, such as cochlear microphonics (CM),auditory nerve neurophonics (ANN), which can reflect immediate changesin the cochlear mechanics and insertion trauma pre-, during-, andpost-insertion of the electrode array. This type of data can be utilizedby the controller circuit 122 to control implant delivery andpositioning in real-time with closed-loop feedback based on the ECoGmeasurements. ECoG recordings are electrical potentials generated in theinner ear, cochlea, and auditory nerve in response to sound orelectrical stimulation, using an electrode placed at the sites such asthe ear canal, tympanic membrane, round window, or intracochlear. Whileauditory brainstem responses (ABRs) reflect electrophysiologicalresponses from different neural generators along the brainstem, cochlearmicrophnics (CM) reflect intracochlear physiology of outer and innerhair cells.

As illustrated in FIG. 6B, the control system 600 can link, couple, orinterface the motion control parameters with real-time, intraoperativeelectrophysiological measures of cochlear function during electrodeinsertion to serve as means to determine and set optimal electrodepositioning. Interoperability can include linking the software/data fromthe electrode array or other intracochlear/extracochlear recordingsduring real-time insertion to the control console feedback mechanism toindicate when optimal electrode position has been achieved based onelectrophysiological measures such as neural response telemetry,auditory nerve neurophonics, or cochlear microphonics.

Decreased ECoGs during or after insertion likely reflect changes incochlear mechanics due to the implant intracochlear position as well asinsertion trauma, which are likely mechanisms of hearing loss afterimplant insertion. For example, CM amplitude changes have been shown tobe most affected by inadvertent movement of the array upon physicalcontact/elevation of the basilar membrane. Therefore, the ability toprovide a real-time monitoring link (via ECoG input 630) and feedback tothe insertion control system 600 to monitor and fine tune the implantposition by robotic-assisted and surgeon controlled micromechanicalposition adjustments until the ECoG measures such as CM are maintainedor optimized per surgeon or audiologist determined preferences. Incertain examples, the user interface module 121 can provide real-timefeedback of the ECoG measures to the surgeon and enable additionalcontrols responsive to ECoG measures and surgeon input.

With the real-time control system link and interface with ECoG measuresduring implant insertion, the system may notify the surgeon of potentialfor real-time physiological injury to intracochlear structures such ascontact with the basilar membrane. If decreases or significant changesare recorded in ECoG measures, the system provides feedback to thesurgeon in the form of visual or audible notifications and a stopcommand may be sent to the system controller to prevent further implantmotion. After the system notification to the user, the surgeon mayadjust implant insertion trajectory or system motion parameters asneeded to avoid intracochlear damage or suboptimal electrode position orchoose to the override notifications via physical acknowledgementmechanism. After acknowledgment of warning notification, the stopfeedback is removed and the surgeon may continue robotic-assistedinsertion of the implant.

FIG. 7 illustrates, by way of example and not limitation, a method 700for delivering and positioning an implant into a target implantationsite of a patient via an external, non-implantable roboticallycontrolled implantation system, such as the robotically assistedimplantation system 100. In an example, the method 700 may be used tooperate the robotically controlled implantation system to advance anelectrode array of a cochlear implant to a target cochlear region torestore hearing loss via electrostimulation. The method 700 may also beused for operating the robotically controlled implantation system todeliver, steer, position, or extract other types of implants orprosthesis. Examples of such implants may include leads, catheter,guidewire, or other mechanical or electrical devices. The implants maybe used for diagnosing a disease or other conditions, or alternativelyor additionally be used in the cure, mitigation, treatment, orprevention of disease, such as implantable electrodes for deliveringelectrostimulation at cardiac, neural, muscular, or other tissues.

The method 700 begins at step 710, where a communication link isestablished between an external positioning unit and a control console.The external positioning unit includes mechanical components forengaging a portion of an elongate member of the implant. The externalpositioning unit may also include a power system with a motor togenerate driving force and motion, and a power transmission unit totransmit the driving force and motion from the motor to motion of theelongate member of the implant. The controller console include circuitryfor generating a motion control signal according to the motion controlinstructions provided by the user. The motion control signal may controlthe power system to regulate one or more motion parameters of theelongate member.

The communication link between the external positioning unit and thecontrol console may include a wired connection including universalserial bus (USB) connection, or otherwise cables coupled tocommunication interfaces on both the control console and the powersystem. In another example, the communication link may include awireless connection including Bluetooth protocol, Bluetooth low energyprotocol, near-field communication (NFC) protocol Ethernet, IEEE 802.11wireless, an inductive telemetry link, or a radio-frequency telemetrylink, among others.

At 720, at least a portion of the elongate member of a cochlear implantmay be engaged to the external positioning unit. The cochlear implantmay include an implantable stimulator for subcutaneous implantationunder the scalp. The implantable stimulator may generateelectrostimulation impulses conducted to the electrode array forstimulating cochlear nerves. The cochlear implant may include anelongate member with an electrode array disposed at a distal portion ofthe elongate member. The external positioning unit may include acoupling unit that may interface with the elongate member. In anexample, the coupling unit may include a drive wheel and an idler wheelarrangement as illustrated in FIGS. 3A-3B. The elongate member of theimplant may be fed through the external positioning unit via an entranceport and an exit port, and compression-engaged between the driver wheeland the idler wheel. The idler wheel may be spring-biased and compressagainst the driver wheel, via a torsion spring. The torsion spring maybe manually biased to release the compression and open the space betweenthe drive wheel and the idler wheel to accommodate the elongate memberinto the external positioning unit.

At 730, the external positioning unit may be affixed to a patient, suchas on the patient head to maintain sufficient stability during theadvancement of the implant. The external positioning unit mayalternatively be securely attached to an object at the patient'simmediate environment such as an equipment attached to a surgical table.As previously discussed with reference to FIG. 1, the externalpositioning unit may be sized and shaped to facilitate patientattachment. The external positioning unit may include a fixation member,such as one or more of a screw, a pin, a nail, a wire, a hook, a suture,or a magnet. The external positioning unit may have an exterior contactsurface with a rough texture, or equipped with one or more grippingelements. Examples of the gripping elements may include penetrators suchas spikes, pins, or barbs protruding from the exterior surface. When theexterior contact surface is in contact with a body part of the patient(e.g., patient head) and the external positioning unit is pressed andheld against the body part, the gripping elements may provide sufficientfriction or gripping force to securely hold the external positioningunit in place during the implant advancement.

At 740, an implant may be delivered and positioned into the targetimplantation site through a robotic control of the external positioningunit. In an example of cochlear implant, the electrode array of thecochlear implant may be inserted into and positioned at the targetcochlear site. In patients with impaired high-frequency hearing functionbut preserved low-frequency hearing function, a short electrode array ofthe implant may be positioned at the outer or basal cochlea.Electrostimulation may be delivered therein via the electrode array torestore high-frequency hearing function. The robotic control of theimplant movement may involve generating a motor control signal from thecontrol console according to user programming instructions. The motorcontrol signal may be transmitted to a motor located inside the controlconsole or inside the external positioning unit. The motor may generatedriving force and motion that control various motion parameters of theelongate member of the implant via the power transmission unit. Thecontrol console may regulate the electrode array movement further basedon sensor feedback on the position of the implant, motion the implant,or the force or friction applied to the implant. Examples of therobotically assisted delivery and positioning of the implant arediscussed below, such as with reference to FIG. 8.

FIG. 8 illustrates, by way of example and not limitation, a method 840for sensor-based robotic control of a cochlear implant. The method 840is an embodiment of the step 740 of the method 700 as illustrated inFIG. 7. The method 840 may be used for operating a non-implantable,robotically controlled implantation system, such as the roboticallyassisted implantation system 100.

Once the external positioning unit is affixed to the patient at 730,motion control parameters may be programmed at 841, such as via the userinterface module 121 of the control console 120. The motion controlparameters may characterize desired motion of the elongate member of theimplant. Examples of the motion parameters may include a target movementrate, a target movement direction or orientation, a target movementdistance, a target position of a distal end of the elongate member, or atarget amount of force imposed on the elongate member. In some examples,a pre-determined implant delivery protocol may be programmed into thesystem. The implant delivery protocol defines target values of aplurality of motion parameters. A user may adjust one or more motionparameters, modify an existing implant delivery protocol, or switch to adifferent implant delivery protocol during the implant deliveryprocedure.

At 842, the elongate member of the implant may be fed into a sheath, anda distal end of the sheath may be introduced to the entrance of thesurgical site, such as a cochlear entrance for cochlear implantplacement. As illustrated in FIGS. 3-4, the sheath may partially orcompletely enclose the elongate member of the implant to provideresilient support to the elongate member, thereby keeping the implant ontrack from the external positioning unit and the surgical entrance ofthe target implantation site. A surgeon may advance the implant throughthe external positioning unit via user input controls on the userinterface module, or through a peripheral input device such as a footpedal or a handheld device, until the distal tip of the elongate memberis in line with distal end of the sheath. The distal end of the sheathmay then be positioned at the entrance to the cochlea. The distal end ofthe sheath may be fixed or reversibly stabilized at a designatedposition of the surgical opening of the implantation. In an example ofcochlear implant, the distal end of the sheath may be stabilized at thecochlea round window (RW) or cochleostomy site by closely matching tubediameters to the RW niche or cochleostomy dimensions.

Once the sheath are positioned and stabilized in place, the implant maybe robotically advanced via the control console or one or more of theperipheral input controls coupled to the control console. At 843, thecurrent implant position may be reset to zero, such as by a short pressof the foot pedal. At 844, the cochlear implant may be delivered andpositioned to the target site of cochlear region, according to theprogrammed motion control parameters. The motion of the implant may beactivated by a surgeon using the control buttons on the control console,or a peripheral control device, such as a foot pedal or a handhelddevice. The movement of the implant may be activated at intervals of apredetermined step size. In an example, for cochlear implant, the targetmovement rate is approximately 100 micron intervals. In an example, thetarget movement distance is approximately 1-35 millimeters.

During the implantation process, one or more sensors may senseinformation about position and motion of the implant at 845. The sensormay be positioned at the electric motor, the power transmission unit, orinside the external positioning unit such as at the drive wheel or idlerwheel. Examples of the sensors may include encoders. Hall effectsensors, or optional sensors for detecting the position of the implant,capacitive sensors for detecting implant motion, or force sensors forsensing a parameter indicative of force or friction imposed on theimplant during the implant advancement, such as axial, lateral, orradial insertion force as the implant advances into the cochlea. Theforce may also be indirectly sensed by measuring the current supplied tothe electric motor.

At 846, the sensor feedback on implant may be transmitted to the controlconsole and output to a user or a process. In an example, ahuman-perceptible presentation of the sensed feedback, including one ormore parameters on the position of the implant, motion of the implant,or the force or friction applied to the implant motion, may begenerated. The presentation may include real-time visual or audiblenotification with specified patterns corresponding to different types ofevents encountered during implantation. The audible and visual feedbackmay also signal to the user that the sensed implant position, motion, orthe forces has exceed the target parameter values such as programmed bythe user.

At 847, the sensor feedback is checked to determine whether targetimplantation site has been reached. A target implantation site isreached if the sensed distance of insertion reaches the user programmedtarget distance within a specified margin. A visual indicator, such as alight emitting diode (LED) or an on-screen visual indicator on thedisplay screen with specified color or pattern may signal to the user asuccessful positioning of the implant at the target implantation site.Alternatively or additionally, an audial notification, such as a beep oran alarm with a specific tone, frequency, or a specific pattern (e.g.,continuous, intermittent, pulsed, sweep-up, or sweep-down sound) may gooff to signal to the user successful positioning of the implant at thetarget implantation site.

If at 847 the target implantation site is not reached, then the deliveryand positioning process may be continued at 844. If at 847 it isdetermined that the target implantation site has been reached, then at848, the implant may be released and positioned at the target implantsite, and the sheath and the external positioning unit may be removed.As illustrated in FIGS. 4A-4C, the sheath may include disengagementmeans to facilitate separation of the sheath from the elongate member,while at the same time avoid excessive damaging forces on the implant,such as to prevent dislodgement of the implant from the implantationsite upon removal of the sheath.

FIG. 9 illustrates, by way of example and not limitation, a method forsensor-based and measurement-based real-time control of implant deliveryand positioning. The method 940, like method 840 discussed above, is anembodiment of the step 740 of the method 700 as illustrated in FIG. 7.The method 940 may be used for operating a non-implantable, roboticallycontrolled implantation system, such as the robotically assistedimplantation system 100. In this example, the method 940 includesoperations identical to method 800 with the addition of receiving ECoGmeasurements at 945. As discussed in reference to FIG. 6B above, theECoG measurements can be utilized by the external positioning unit 110and/or control console 120 to assist in controlling implant positioningand delivery. As illustrated in FIG. 9, the method 940 can include anoperation for receiving ECoG measurements, which can then be utilized indetermining whether a target site is reached at 847. As discussed above,ECoG measurements can be monitored to determine when an optimal implantposition is reached or for potential issues with the implant delivery.

FIGS. 10A-10B illustrate, by way of example and not limitation, aportion of an external positioning unit configured to deliver andposition a guide sheath and an implantable electrode. Similar to FIGS.4A-4C, these figures expound on the example external positioning devicesillustrated in FIGS. 3A-3B. External positioning units 1000A and 1000Billustrate alterations to the external positioning units discussed aboveto handle positioning of both an electrode (elongate implant) as well asa guide sheath, such as insertion sheath 1002 (also referenced as aninternal sheath). Similar to the systems discussed above, the externalpositioning units 1000A/1000B include a guide sheath 1003 that can befixed to the external positioning unit. Within the guide sheath 1003 isan insertion sheath 1002 and an electrode implant 1001. The otheraddition illustrated in FIGS. 10A-10B are another set of drive and guidewheels (see spring loaded sheath wheel 1031 and sheath drive wheel 1021as well as spring-loaded electrode wheel 1030 and drive wheel 1020.

As mentioned above, intracochlear trauma can occur from large pressurespikes generated during the insertion of cochlear implant electrodes.Similar fluid and force spikes can be elicited from any solid orflexible bodies, tubes, or sheaths inserted into the cochlea. Thesepressures spikes may be of sufficient intensity to cause trauma similarto that of an acoustic blast injury and are one likely source forpostoperative loss of residual hearing.

Similar to the insertion trauma cause by electrode insertion, the manualinsertion of a sheath or other solid body/tube manually into the cochleamay cause intracochlear fluid pressure spikes and result inintrachochlear damage. To help preserve residual hearing and preventthese traumatic events from manual, un-assisted implantations, externalpositioning unit 1000A/1000B includes an additional method to performguide sheath or insertion sheath insertion near or into the cochleautilizing the robotic-assisted stage and control console system. Thesystem's micro-mechanical movements and control of both the implant,guide sheath or insertion sheath serves to reduce the magnitude andfrequency of both insertion pressure and insertion forces duringcochlear implantation.

In this example, the guide sheath 1003 supports and internally houses aninsertion sheath/tube 1002 in a telescoping fashion. The insertionsheath 1002 can slide within the guide sheath 1003 and over theelectrode implant 1001 also housed within. The insertion sheath 1002moves through the guide sheath 1003 (affixed to the external positioningunit proximally) and over the implant 1001 on the abluminal side within.This enables controlled robotic movement of both the insertion sheath1002 and implant 1001 into the delicate intracochlear space.

The system may be capable of parallel telescoping or rotationalmovements of both insertion sheaths and implant within a guide sheath ina coordinated, surgeon controlled fashion utilizing two or more couplingunits within the external positioning unit. There may either be twoindependent drive wheel coupling systems each controlling the sheath andelectrode insertion independently or in parallel, coordinated motions.After the end of the internal insertion sheath is inserted a distancethat passes the distal coupling unit and travels out of the compressivegrasp, the spring-loaded wheel will disengage from the internalinsertion sheath and clamp onto the internal electrode implant. The nowdirectly interface implant is then controlled robotically with the samedrive wheel control unit via user controlled motion parameters.

FIG. 10A illustrates the insertion sheath 1002 engaged withspring-loaded sheath wheel 1031 and sheath drive wheel 1021, which arecontrolling positioning of the insertion sheath 1002. The electrodeimplant 1001 is engaged by spring-loaded electrode wheel 1030 andelectrode drive wheel 1020. In this example, the insertion sheath 1002may be fully positioned, as the external positioning unit 1000A isengaged with the electrode implant.

FIG. 10B illustrates the insertion sheath 1002 engaged with both drivemechanisms within the external positioning unit 1000B. In this example,the spring-loaded sheath wheel 1031 and sheath drive wheel 1021 as wellas the spring-loaded electrode wheel 1030 and electrode drive wheel 1020are engaged with the insertion sheath 1002. In this example, theinsertion sheath 1002 is still in the process of beingpositioned/delivered.

In these examples, systems for cochlear implant insertion are described,but the method and systems can apply to any thin cylinder, tubular orelongate member such as a sheath, neurostimulators, electrodes, orcatheters insertion into any body tissue, cavity, or fluid filled space.

FIG. 11 illustrates, by way of example and not limitation, a method forreal-time control of implant and guide sheath delivery and positioning.The method 1140, like methods 840 and 940 discussed above, is anembodiment of the step 740 of the method 700 as illustrated in FIG. 7.The method 1140 may be used for operating a non-implantable, roboticallycontrolled implantation system, such as the robotically assistedimplantation system 100. In this example, the method 1140 includesoperations identical to method 840 with the addition of operations formonitoring the positioning and delivery of an insertion sheath, such asinsertion sheath 1002. As illustrated, the method 1140 includesadditional operations 1154 and 1157 for delivering and/or positioning asheath at 1154 and determining whether the sheath has reached the targetposition at 1157. Monitoring the sheath insertion can involve similarsensor feedback as used with electrode insertion. Otherwise, theoperations of method 1140 mirror those discussed in reference to methods840 and 940 above.

FIGS. 12A-12C illustrate, by way of example and not limitation, diagramsof different views of a portion of an external positioning unit 1200,which represents an embodiment of the external positioning unit 110 asillustrated in FIG. 1. FIG. 12A is a perspective diagram of the externalpositioning unit 1200. The external positioning unit 1200 includes aunit body 1202, and first and second arms 1203 and 1204 extending fromthe unit body 1202. The unit body 1202 and the first and second arms1203 and 1204 house an assembly of electro-mechanical componentsinterconnected to engage an elongate member 301 and robotically deliverand position the implant attached to the elongate member 301 into atarget implantation site. The external positioning unit 1200 includes apower or charging cable 1211, and one or more of control andcommunication cables 1212 and 1213 to receive signals to control themotor output and thus the motion of the implant. In an example, theexternal positioning unit 1200 may include a battery as power source.The battery may be a rechargeable battery. The first and second arms1203 and 1204 may each house respective coupling units at their distalends that are in movable contact with each other, such as the couplingunit 111 and 211 as discussed above with reference to FIGS. 1-2.

As illustrated in FIG. 12A, the first and second arms 1203 and 1204 mayeach be tilted at an angle with respect to the plane of the unit body1202, and operably form an open space 1205 to accommodate at least aportion of the elongate member 301. In various examples, the first andsecond arms 1203 and 1204 may be multiple degrees of freedom of tilt todifferent axes. The tilted arms and the open space in between may alsoallow the elongate member 301 to move longitudinally without beinginterfered by the unit body 1202.

FIG. 12B is a cutaway view of the external positioning unit 1200 thatillustrates an electro-mechanical assembly enclosed by a housing 1210.The unit body 1202 houses an electric motor 1242 that may generatedriving force and motion according to a motion control signal, such asprovided by the control console 120 and transmitted through the controland communication cable 1212. The electric motor 1242 is coupled to apower transmission unit 1244, which represents an embodiment of thepower transmission unit 232 as illustrated in FIG. 2. By way of exampleand not limitation, the power transmission unit 1244 may include aseries of pulleys connected by belts (not shown). Rotation of thepulleys may transmit the power to a drive wheel 1220 enclosed in thefirst arm 1203. Similar to the drive wheel 320 in FIG. 3A, the drivewheel 1220 may rotate on an axle securely attached to the housing 1210.

Enclosed in the second arm 1204 may include an idler wheel 1230, whichis an embodiment of the idler wheel 320 in FIG. 3A. The idler wheel 1230may be coupled to a biasing system that includes a spring-loaded lever1254 coupled to a torsion spring 1252. The second arm 1204 mayadditionally house a sensor to sense motion parameters. FIG. 12Cillustrates an embodiment of such a sensor. An encoder sensor 1231 maysense the rotation of the idler wheel 1230 (thus the motion parametersof the elongate member 301) via an encoder wheel 1232 attached to theidler wheel 1230. Examples of the encoder sensor 1231 may includeoptical, capacitive, or Hall effect based sensors. The spring-loadedlever 1254, through a spring bias 1256, may support the idler wheel1230, and provide lateral compression against the drive wheel 1220. Thetension generated by the torsion spring 1252 may be relayed to the idlerwheel 1230 via the spring-loaded lever 1254, and compress against thedrive wheel 1220 to generate adequate friction on the elongate member301. Depending on the motion control signal input to the motor 1242, thepower transmission unit 1244 may drive rotation of the drive wheel 1220,which in turn propels the implant to a specific direction (e.g., forwardor backward) at a specific rate. As illustrated in FIG. 12B, the torsionspring 1252 may be coupled to a button 1252 that allows a user tocontrol the spring tension. For example, a user may push the button 1252to release the compression and open the idler wheel 1230 away from thedrive wheel 320. In some examples, the release of the compression mayallow a user to easily move the second arm 1204 away from the first arm1203. The user may then remove the elongate member 301, or load anotherimplant with an elongate member into the external positioning units1200. Because the idler wheel 1230 is held in place by the biasingsystem, the idler wheel 1230 may move laterally relative to the housing1210, thus may accommodate elongate members with various diameters orcross-sectional shapes, while maintaining sufficient friction on theelongate member for desirable movement.

FIGS. 13A-13B illustrates, by way of example and not limitation,diagrams a portion of the external positioning unit 1200 coupled to aremovable guide sheath 1360. The guide sheath 1360 represents anembodiment of the sheath 360 or one of 460A-460C. In the illustratedexample, the guide sheath 1360 comprises two separable portions 1360Aand 1360B removably affixed to the first and second arms 1203 and 1204,respectively. FIG. 13A illustrates the sheath portions 1360A and 1360Bin open position. When the second arm 1204 is moved away from the firstarm 1203 such as via the spring mechanism in the spring-loaded lever1254, the sheath portion 1360B, affixed to the second arm 1204, may beseparated and moved away from the sheath portion 1360A. FIG. 13Billustrates the sheath portions 1360A and 1360B in closed position,which can be achieved by moving the second arm 1204 towards the firstarm 1203. The closed position may be maintained by the compressionprovided by the spring-loaded lever 1254. The closure of the sheathportions 1360A and 1360B may at least partially enclose the elongatemember 301 to provide resilient support to the elongate member 301 ofthe implant, prevent buckling in the implant from the controlled forceof the insertion device, and keep the implant on track during guidedimplant delivery, such as insertion into the implant site. Once theimplant is fully inserted, the guide sheath 1360 may be safely removed,such as tom apart through linear perforations. In an example of cochlearimplant, the guide sheath 1360A-1360B is flexible to direct distal endto the round window or cochleostomy insertion site.

In some examples, as illustrated in FIG. 15B, a sensing probe 1370 maybe attached to the guide sheath 1360 to measure a physiologic signal,such as electrocochleography (EcoG) during cochlea implantation. In anexample, the sensing probe 1370 may include an electrically conductivewire encompassed in the sheath material or via a separate sheathchannel. By way of example and not limitation, the conductive wire maybe made out of platinum, palladium, iridium, gold, or alloys. The wirehas an exposed distal electrode that makes direct contact with the boneat the round window niche via a ball tip or wire loop end. This sensingelectrode or probe interfaces at its proximal end with the maininsertion system unit processor as an integrated sensing electrode. TheEcoG measures obtained via the sensing electrode tip at the round windowmay be used as a physiologic feedback to optimize the insertion systemcontrol and positioning of the cochlear implant electrode.

FIG. 14 illustrates, by way of example and not limitation, a diagram ofan external positioning unit 1410 mounted on an adjustable arm 1420. Theadjustable arm 1420 can be a hollow, flexible, malleable arm such as agooseneck tubing, as illustrated in FIG. 14. The adjustable arm 1420 isconfigured to allow the user to position the trajectory prior toinsertion of the elongate member 301. The external positioning unit 1410represents an embodiment of one of the external positioning unit 300A,300B, 500, or a variation thereof, and can be attached to a distal end1422 of the adjustable arm 1420 via detachable couplings. The goosenecktubing is flexible, yet rigid and adjustable to hold the externalpositioning unit 1410 at user manually-set positions in space relativeto the patient. In an example, one or more of the first and second arms1203 and 1204 of the external positioning unit 1200 may take the form ofthe gooseneck tubing as illustrated in FIG. 14. The gooseneck tubing maysupport and hold in position the distal coupling units (e.g., the drivewheel 1220 and the idler wheel 1230), and acts as conduit for internalcables. In various examples, at least a portion of the motor 1242, thepower transmission unit 1244, and drive cable (such as rotating shaft356) may be housed within the hollow space of the flexible goosenecktubing that snakes down to the coupling units at the distal end. Thiswould provide surgeon flexibility to mechanically adjust the trajectoryof insertion of the elongate member 301.

Various embodiments are illustrated in the figures above. One or morefeatures from one or more of these embodiments may be combined to formother embodiments.

The method examples described herein can be machine orcomputer-implemented at least in part. Some examples may include acomputer-readable medium or machine-readable medium encoded withinstructions operable to configure an electronic device or system toperform methods as described in the above examples. An implementation ofsuch methods may include code, such as microcode, assembly languagecode, a higher-level language code, or the like. Such code may includecomputer readable instructions for performing various methods. The codecan form portions of computer program products. Further, the code can betangibly stored on one or more volatile or non-volatilecomputer-readable media during execution or at other times.

The above detailed description is intended to be illustrative, and notrestrictive. The scope of the disclosure should, therefore, bedetermined with references to the appended claims, along with the fullscope of equivalents to which such claims are entitled.

What is claimed is:
 1. A system for robotically assisted implantation or manipulation of an implant in a patient, the system comprising: a positioning unit including at least two rollers arranged to engage, through compression between respective radial outer surfaces of the at least two rollers, at least a portion of an elongate member of the implant; a control console configured to generate a motion control signal for controllably driving rotation of at least one motorized roller of the at least two rollers, said rotation actuating a translational motion or a rotational motion of the elongate member via friction generated by the compression.
 2. The system of claim 1, wherein the positioning unit is an implantable unit.
 3. The system of claim 1, wherein the positioning unit is a non-implantable unit comprising a fixation member configured to detachably affix the positioning unit externally to the patient.
 4. The system of claim 1, comprising a motor configured to, in response to the motion control signal, drive rotation of the at least one motorized roller via a power transmission unit.
 5. The system of claim 4, comprising a rechargeable power source to power the motor.
 6. The system of claim 4, wherein the motor is coupled to the at least one motorized roller via a shaft running between the control console and the positioning unit.
 7. The system of claim 4, wherein the motor is configured to drive the rotation of the at least one motorized roller to actuate the translational motion or the rotational motion of the elongate member to propel the implant to a body site.
 8. The system of claim 7, comprising an electrical stimulator electrically coupled to an electrode disposed on the implant to deliver electrostimulation at the body site.
 9. The system of claim 1, wherein the implant includes a guidewire or a guide sheath, and the at least two rollers are arranged to engage an elongate portion of the guidewire or the guide sheath.
 10. The system of claim 1, wherein the control console is configured to receive a user input of at least one motion parameter, and to generate the motion control signal in accordance with the user input of the at least one motion parameter to regulate motion of the elongate member.
 11. The system of claim 10, wherein the at least one motion parameter includes one or more of a movement rate, a movement direction or orientation, a movement distance, a position of a distal end of the elongate member, or an amount of force imposed on the elongate member.
 12. The system of claim 1, comprising a peripheral control unit configured to receive a user input for the control console to generate the motion control signal, the peripheral control unit including one or more of a foot pedal or a handheld device.
 13. The system of claim 1, wherein the control console is configured to receive information about a medical history or disease state of the patient, and to generate the motion control signal further in accordance with the received information about the patient medical history or disease state.
 14. The system of claim 1, further comprising one or more sensors coupled to or included in the positioning unit, the one or more sensors configured to sense a motion of the implant, wherein the control console is configured to generate the motion control signal in accordance with the sensed motion of the implant.
 15. The system of claim 1, further comprising one or more sensors configured to sense physiological information from the patient, wherein the control console is configured to generate the motion control signal in accordance with the sensed physiological information.
 16. An apparatus for robotically assisted implantation or manipulation of an implant, the apparatus comprising: a positioning unit including at least two rollers arranged to compress at least a portion of an elongate member of the implant between portions of a radial outer surface of each of the at least two rollers; wherein the at least two rollers includes at least one motorized roller configured to, in response to a motion control signal, be driven to rotate against another of the at least two rollers to transmit translational or rotational forces to the elongate member.
 17. The apparatus of claim 16, wherein the positioning unit includes a power transmission unit configured to transmit force from a motor to the at least one motorized roller.
 18. The apparatus of claim 17, comprising: a communicator circuit configured to receive the motion control signal; and the motor configured to, in response to the motion control signal, drive rotation of the at least one motorized roller via the power transmission unit.
 19. The apparatus of claim 16, comprising: one or more sensors coupled to or included in the positioning unit, the one or more sensors configured to sense a motion of the implant; and control circuitry configured to generate the motion control signal in accordance with the sensed motion of the implant.
 20. A method for robotically implanting or manipulating an implant with an elongate member via an implant positioning unit, the method comprising: engaging at least a portion of the elongate member through compression between respective radial outer surfaces of at least two rollers arranged in the positioning unit, the at least two rollers including at least one motorized roller operably driven by a motor; implanting, or affixing externally, the positioning unit to a patient: generating a motion control signal using a control console; and in response to the motion control signal, robotically driving rotation of the at least one motorized roller against another of the at least two rollers via the motor and a power transmission unit to transmit translational or rotational forces to the elongate member.
 21. The method of claim 20, further comprising sensing a motion of the implant using one or more sensors, wherein generating the motion control signal is in accordance with the sensed motion of the implant.
 22. The method of claim 20, further comprising sensing physiological information from the patient using one or more sensors, wherein generating the motion control signal is in accordance with the sensed physiological information.
 23. The method of claim 20, further comprising receiving information about a medical history or disease state of the patient, wherein generating the motion control signal is in accordance with the received information about the patient medical history or disease state. 